Limits...
Cost-Effectiveness of Administering Rituximab for Steroid-Dependent Nephrotic Syndrome and Frequently Relapsing Nephrotic Syndrome: A Preliminary Study in Japan

View Article: PubMed Central - PubMed

ABSTRACT

With regard to the use of rituximab for patients with steroid-dependent nephrotic syndrome and frequently relapsing nephrotic syndrome, not only has the regimen not been clinically verified but also there is a lack of health economics evidence. Therefore, we conducted a prospective clinical study on 30 patients before (with steroids and immunosuppressants) and after introducing rituximab therapy. Relapse rates and total invoiced medical expenses were selected as the primary endpoints for treatment effectiveness and treatment costs, respectively. As secondary endpoints, cost-effectiveness was compared before and after administering rituximab in relation to previous pharmacotherapy. The observation period was 24 months before and after the initiation of rituximab. We showed that there was a statistically significant improvement in the relapse rate from a mean of 4.30 events before administration to a mean of 0.27 events after administration and that there was a significantly better prognosis in the cumulative avoidance of relapse rate by Kaplan–Meier analysis (p < 0.01). Finally, the total medical costs decreased from 2,923 USD to 1,280 USD per month, and the pre–post cost-effectiveness was confirmed as dominant. We, therefore, conclude that treatment with rituximab was possibly superior to previous pharmacological treatments from a health economics perspective.

No MeSH data available.


Related in: MedlinePlus

Kaplan–Meier curves of cumulative avoidance rate of the first relapse.(a) This estimate was compared before and after administering rituximab, for 24 months in each direction. In this way, rituximab was compared to previous pharmacotherapy. (b) Avoidance number of the first relapse.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC5384079&req=5

f1: Kaplan–Meier curves of cumulative avoidance rate of the first relapse.(a) This estimate was compared before and after administering rituximab, for 24 months in each direction. In this way, rituximab was compared to previous pharmacotherapy. (b) Avoidance number of the first relapse.

Mentions: When analyzing the clinical features before and after rituximab was added, the number of patients with relapse and total number of relapses were significantly lower (30 vs 6; p < 0.01, 129 vs 8; p < 0.01). Comparison of the total number of relapses between the 24-month period before the first rituximab injection and the 24-month period after the first rituximab injection revealed a significantly lower number of relapses during the latter period (4.30 ± 2.76 times per 24 months vs 0.27 ± 0.52 times per 24 months; p < 0.01) (Table 2). When comparing by classification of age group (based on 18 years), there was no significant difference in the relapse rate (4.25 for ≤ 18 years (n = 5) vs. 4.31 for ≥19 years (n = 25); p > 0.05). Urinary protein level, which was 2.1 ± 4.6 g/day before rituximab, improved to 0.0 ± 0.0 g/day after rituximab (p < 0.05). Although serum creatinine level (0.7 mg/day) did not show a major change from before to after rituximab therapy, serum albumin (3.6 ± 0.9 g/dL to 4.6 ± 0.3 g/dL) and total cholesterol (287.0 ± 112.1 mg/dL to 185.3 ± 38.7 mg/dL) levels did improve (p < 0.05). CD20 antigen levels were 7.8% ± 5.2% before rituximab and were significantly reduced to 0.7% ± 1.0% at 24 months after administration (p < 0.01). The bone mineral density and T and Z scores were significantly higher at 24 months than at the baseline (0.83 ± 0.15 vs. 0.94 ± 0.13; p < 0.05, −1.65 ± 1.38 vs. −0.73 ± 0.78; p < 0.01, −1.63 ± 1.41 vs. −0.67 ± 1.01; p < 0.01), and the number of patients requiring bisphosphonates was also significantly lower at the end of the 24-month observation period (30 vs 12; p < 0.01). The prednisolone dose decreased significantly from 24.1 ± 13.4 mg/day before rituximab to 0.2 ± 0.6 mg/day after administration (p < 0.01). Also, the cyclosporine dose decreased from 89.8 ± 64.5 mg/day before rituximab to 12.5 ± 29.1 mg/day after administration (p < 0.01). The Kaplan–Meier analysis indicated that patients given rituximab had significantly better prognosis in the cumulative avoidance rate of the first relapse (p < 0.01) (Fig. 1).


Cost-Effectiveness of Administering Rituximab for Steroid-Dependent Nephrotic Syndrome and Frequently Relapsing Nephrotic Syndrome: A Preliminary Study in Japan
Kaplan–Meier curves of cumulative avoidance rate of the first relapse.(a) This estimate was compared before and after administering rituximab, for 24 months in each direction. In this way, rituximab was compared to previous pharmacotherapy. (b) Avoidance number of the first relapse.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5384079&req=5

f1: Kaplan–Meier curves of cumulative avoidance rate of the first relapse.(a) This estimate was compared before and after administering rituximab, for 24 months in each direction. In this way, rituximab was compared to previous pharmacotherapy. (b) Avoidance number of the first relapse.
Mentions: When analyzing the clinical features before and after rituximab was added, the number of patients with relapse and total number of relapses were significantly lower (30 vs 6; p < 0.01, 129 vs 8; p < 0.01). Comparison of the total number of relapses between the 24-month period before the first rituximab injection and the 24-month period after the first rituximab injection revealed a significantly lower number of relapses during the latter period (4.30 ± 2.76 times per 24 months vs 0.27 ± 0.52 times per 24 months; p < 0.01) (Table 2). When comparing by classification of age group (based on 18 years), there was no significant difference in the relapse rate (4.25 for ≤ 18 years (n = 5) vs. 4.31 for ≥19 years (n = 25); p > 0.05). Urinary protein level, which was 2.1 ± 4.6 g/day before rituximab, improved to 0.0 ± 0.0 g/day after rituximab (p < 0.05). Although serum creatinine level (0.7 mg/day) did not show a major change from before to after rituximab therapy, serum albumin (3.6 ± 0.9 g/dL to 4.6 ± 0.3 g/dL) and total cholesterol (287.0 ± 112.1 mg/dL to 185.3 ± 38.7 mg/dL) levels did improve (p < 0.05). CD20 antigen levels were 7.8% ± 5.2% before rituximab and were significantly reduced to 0.7% ± 1.0% at 24 months after administration (p < 0.01). The bone mineral density and T and Z scores were significantly higher at 24 months than at the baseline (0.83 ± 0.15 vs. 0.94 ± 0.13; p < 0.05, −1.65 ± 1.38 vs. −0.73 ± 0.78; p < 0.01, −1.63 ± 1.41 vs. −0.67 ± 1.01; p < 0.01), and the number of patients requiring bisphosphonates was also significantly lower at the end of the 24-month observation period (30 vs 12; p < 0.01). The prednisolone dose decreased significantly from 24.1 ± 13.4 mg/day before rituximab to 0.2 ± 0.6 mg/day after administration (p < 0.01). Also, the cyclosporine dose decreased from 89.8 ± 64.5 mg/day before rituximab to 12.5 ± 29.1 mg/day after administration (p < 0.01). The Kaplan–Meier analysis indicated that patients given rituximab had significantly better prognosis in the cumulative avoidance rate of the first relapse (p < 0.01) (Fig. 1).

View Article: PubMed Central - PubMed

ABSTRACT

With regard to the use of rituximab for patients with steroid-dependent nephrotic syndrome and frequently relapsing nephrotic syndrome, not only has the regimen not been clinically verified but also there is a lack of health economics evidence. Therefore, we conducted a prospective clinical study on 30 patients before (with steroids and immunosuppressants) and after introducing rituximab therapy. Relapse rates and total invoiced medical expenses were selected as the primary endpoints for treatment effectiveness and treatment costs, respectively. As secondary endpoints, cost-effectiveness was compared before and after administering rituximab in relation to previous pharmacotherapy. The observation period was 24 months before and after the initiation of rituximab. We showed that there was a statistically significant improvement in the relapse rate from a mean of 4.30 events before administration to a mean of 0.27 events after administration and that there was a significantly better prognosis in the cumulative avoidance of relapse rate by Kaplan&ndash;Meier analysis (p&thinsp;&lt;&thinsp;0.01). Finally, the total medical costs decreased from 2,923&thinsp;USD to 1,280&thinsp;USD per month, and the pre&ndash;post cost-effectiveness was confirmed as dominant. We, therefore, conclude that treatment with rituximab was possibly superior to previous pharmacological treatments from a health economics perspective.

No MeSH data available.


Related in: MedlinePlus